ADB PHARMA ensures the planning, the realization and the follow-up of your projects, in an international environment, for the following fields:
PHARMACEUTICAL DEVELOPMENT
- Development of new chemical entities (NCEs) or biotechnologies
- Set-up of product profiles : benefit/risks analyzes, market positioning, competitive environment, opportunity/innovation
- Strategic development of final pharmaceutical products including the development of analytics and processes, stability studies, and the research and selection of subcontractors
- Definition, coordination and operational management of projects (preclinical, CMC, private clinics)
- Commercial prospecting
DEVELOPMENT OF THE PROCESSES
- Expertise in microbial fermentation, cellular culture, expression of recombining proteins and plasmids, production of oligonucleotides (aptamers), screening of molecules, purification of natural products and biomolecules, and biocatalysis
- Strategic and technical development, including comprehensive plan creation (costs, quality, times, critical path)
- Search for and audit of subcontractors for pilot or industrial transfer
REGULATORY AFFAIRS
- Regulatory follow-up and review
- Preparation and compilation of regulatory files (DMF, CTX, IND, NDA, etc.)
- Coordination and follow-up of file submissions at European or American agencies
- Pharmaceutical responsibility if needed
QUALITY ASSURANCE
- Set up of Quality Assurance systems
- Application of standard industry references : BPF, cGMP, ISO 9000, 9001, 14001, 13485, 13488
- Directives for EC labeling of medical devices
- Quality audits:
Internal –Organizational, techniques, processes
External—Suppliers, subcontractors
- Qualification of equipment: DQ, IQ, OQ,PQ
- Writing of procedures, reports and quality handbooks
- Staff training
MARKETING – SALES
Strategic Marketing: marketing plans, competitor’s analysis, market research, drawing up of the specifications, catalogues, prices and packaging of products, management of conception group of Surgeons, interface for new project development.
Operational Marketing: elaboration of promotional and communication tools (brochures, CD Rom, web sites…), sales training,
Thanks to ADB PHARMA’s access to multiple competencies in product development, our approach can be shown in three main phases:
PHASE 1
- Feasibility study and analysis of your project by the ADB team. One of our experts then becomes your exclusive contact and liaison.
- Definition of the specifications book for the product
- Full product development plan with integration of all experimental phases (including resource allocation) to be carried out in-house or through external sources
- Project set-up and follow-up
PHASE 2
- Drafting of product specifications and search for partners for all appropriate stages, including production, formulation, stability testing, etc.
- Compilation of data and regulatory files for subsequent submission to health agencies (preclinical and clinical files, DMF, etc.)
- Drafting of technical dossiers and legal declarations (GMO, chemicals, dangerous products, etc.)
PHASE 3
- Diagnostic audits, Quality, Safety and Environment
- Design, installation and declaration of premises
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Scope of Activities 
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